Corrective Actions Priority - Process FMEA (PFMEA) RPN Limits - Recommended Actions

M

Michael Walmsley

#11
Re: Corrective Actions Priority - RPN limits

Why have mandatory action for severity 9 or 10? If OCC is 1 and DET is 1 it is likely that you cannot reduce risk further.

Do not work to thresholds (max rpn) as engineers whom are good at math will modify the numbers to reach the threshold. Instead work on reducing the high risk numbers that can be reduced with given available resources.
Why have mandatory action for 9 or 10?
Because it is required in the auto industry regardless of the Occ or Det level.
Reason : Historical product safety recalls , product liability lawsuits and NTHSA levels for investigation kickoff.

In the Pharma where I work now , we elected to maintain that logic.

NOTE that mandatory does not mean immediate action. IT IS subject to resource availability. The actions must be on your planning horizon.

Outside of these required issues,What Brutas is looking for is when can he feasibly stop.
 
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T

tac123

#12
For continous improvement the risk reduction process should never end but for financial reason it may no longer make sense to reduce RPN further.
 
T

tac123

#13
Re: Corrective Actions Priority - RPN limits

Why have mandatory action for 9 or 10?
Because it is required in the auto industry regardless of the Occ or Det level.
Reason : Historical product safety recalls , product liability lawsuits and NTHSA levels for investigation kickoff.

In the Pharma where I work now , we elected to maintain that logic.

NOTE that mandatory does not mean immediate action. IT IS subject to resource availability. The actions must be on your planning horizon.

Outside of these required issues,What Brutas is looking for is when can he feasibly stop.
What action can you take reduce risk further in the case where severity is 10 and Occ and Det is 1?

As an example if a seatbelt breaks you have a sever effect. How can you reduce this RPN further? Sev 10 Occ 1, Det 1.
 
T

tac123

#15
I was expecting that answer. Another answer I've heard was to stop making seat belts and start making cup holders.

For any items in which the sole function is safety related you have to remove the functional requirement for the item in order to reduce the severity or perhaps add redundancy.
 
M

Michael Walmsley

#16
And another would be to consider implementing auxiliary systems such as air bags in conjunction with the safety belts.

I have not personally noted a seat belt system with S=10 , O=D=1.

More in the line of S=9 , O=2 and D=1.
The seat belt alarm/buzzer accounts for the reduction in severity.

The controllers they are putting into the vehicles today monitor the status of many critical systems in an effort to enhance safety and reduce OEM liability.

If someone does not wish to use the belt,it is duly recorded. The FMEA then
conveys that it is not controllable at your level. You can pursue no further action. It should be mentioned in your FMEA as such.

Another would be to consider the level at which the belts were qualified to w/r to vehicle impacts.

If the impact was outside of the range qualified against (exceeds), there is nothing you can do. Again,it should be mentioned in your FMEA as such.
 

Helmut Jilling

Auditor / Consultant
#17
Re: Corrective Actions Priority - RPN limits

What action can you take reduce risk further in the case where severity is 10 and Occ and Det is 1?

As an example if a seatbelt breaks you have a sever effect. How can you reduce this RPN further? Sev 10 Occ 1, Det 1.

I don't recall a requirement that further action must be taken. Perhaps I'm wrong (gosh, as an auditor I would hate to have THAT happen!), but I believe the requirement is that further action be considered.

It might well be, in this example, there is no further action possible.

Also, a seatbelt breaking would be a product failure, and belongs on the DFMEA. It is not a process failure and would not likely be on the PFMEA. Unless of course the failure mode is that the process damaged or cut the seatbelt, which could have the impact that it would break.
 
M

Michael Walmsley

#18
See the attached. I also conducted a stint as an ISO/QS/TS auditor.

As you may recall all shoulds are now shalls which mean mandatory.

The customer specific requirements (not mentioned by the original poster) would also have an impact and further enhance on the content of the guideline.
 

Attachments

Helmut Jilling

Auditor / Consultant
#19
See the attached. I also conducted a stint as an ISO/QS/TS auditor.

As you may recall all shoulds are now shalls which mean mandatory.

The customer specific requirements (not mentioned by the original poster) would also have an impact and further enhance on the content of the guideline.

Thanks for the scan, I was recalling the same text, pretty much. But, to the original OP, when they have done all they can, there is nothing else one can require of them. If there is a seatbelt, the risk remains. But, at an RPN of 10-20, they have done all they can do.
 
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